Senate Bill sb0402e1

    CS for SB 402                            First Engrossed (ntc)



  1                      A bill to be entitled

  2         An act relating to pharmacy; providing a short

  3         title; defining the term "pharmaceutical

  4         adverse incident" and requiring that such

  5         incidents be reported to the Department of

  6         Health; providing exceptions; requiring the

  7         department to review reported incidents to

  8         determine whether the incidents potentially

  9         involve conduct by a health care practitioner

10         that is subject to disciplinary action;

11         specifying that any disciplinary action shall

12         be taken by the appropriate board; providing

13         for the adoption of rules and forms; providing

14         effective dates.

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16  Be It Enacted by the Legislature of the State of Florida:

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18         Section 1.  This act may be cited as the "Ernest Belles

19  Act."

20         Section 2.  (1)  As used in this section, the term

21  "pharmaceutical adverse incident" means the dispensing of a

22  different medication, a different dose, or the correct

23  medication in a container with different instructions than

24  those specified in the prescription, which dispensation

25  results in actual harm to a patient, but does not include the

26  dispensing of a generic equivalent medication with the

27  patient's consent.

28         (2)  A pharmacist licensed under chapter 465, Florida

29  Statutes, or other health care practitioner as defined in

30  section 456.001, Florida Statutes, who becomes aware of a

31  patient's allegation that a pharmaceutical adverse incident


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    CS for SB 402                            First Engrossed (ntc)



  1  has occurred which was caused by a health care practitioner,

  2  must report such allegation to the Department of Health on

  3  forms provided by the department. This section does not apply

  4  to:

  5         (a)  Pharmacists employed by pharmacies that

  6  participate in the program provided by Rule 64B16-27.300,

  7  Florida Administrative Code or health care practitioners

  8  working in facilities that administer medications dispensed

  9  from those pharmacies; or

10         (b)  Pharmacists employed by pharmacies that have

11  notified the Board of Pharmacy that they will establish a

12  continuous quality-improvement program consistent with the

13  requirements of Rule 64B16-27.300, Florida Administrative

14  Code.

15         (3)  The required notification to the department must

16  be submitted in writing by certified mail and postmarked

17  within 15 days after the pharmacist or health care

18  practitioner became aware of the patient's allegation that a

19  pharmaceutical adverse incident has occurred.

20         (4)  Effective July 1, 2004, subject to subsequent act

21  of the Legislature and a specific appropriation sufficient to

22  cover the actual costs, the department shall review each

23  incident and determine whether it potentially involved conduct

24  by a pharmacist or health care practitioner who is subject to

25  disciplinary action, in which case section 465.073, Florida

26  Statutes, applies.  Disciplinary action, if any, shall be

27  taken by the board under which the pharmacist or health care

28  practitioner is licensed.

29         (5)  The Department of Health shall adopt forms and

30  rules for administering this section.

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    CS for SB 402                            First Engrossed (ntc)



  1         Section 3.  Section 2 of this act shall take effect

  2  only upon the effective date of legislation that makes any

  3  such information provided to the Department of Health

  4  confidential and exempt from section 119.07(1), Florida

  5  Statutes, and Section 24(a) of Article I of the State

  6  Constitution, until 10 days after probable cause is found that

  7  a violation of law occurred. Such legislation must also

  8  provide that information may be used by the department or the

  9  Board of Pharmacy only in a disciplinary proceeding brought

10  against the pharmacist or by the department in any study of

11  adverse incidents without identifying the patient, pharmacist,

12  pharmacy, office, or entity by name, location, or other

13  identifier.

14         Section 4.  Except as otherwise expressly provided in

15  this act, this act shall take effect July 1, 2002.

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